Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral LD50 > 4000 mg/kg bw/d.

Inhalation LC50 > 4.74 mg/L.

Key value for chemical safety assessment

Additional information

The LD50 studies presented indicate low acute oral toxicity in rats, with LD50 values varying from >4,000 mg/kg bw up to 7,334 mg/kg bw. Considering the history of human use of sodium bicarbonate, the effects of oral exposure are well known due to accidental and intentional ingestion by humans, and it is considered safe to ingest up to 4 g/dose.

The inhalation toxicity study indicated a low toxic potential, as the LC50 was >4.74 mg/L.

[partly taken from OECD SIDS on sodium bicarbonate (2002), pg. 15]

Justification for classification or non-classification

Based on the results described, the substance does not need to be classified for acute toxicity according to CLP Regulation (EC) No 1272/2008.